A variety of products such as gowns, sheets, drapes, instruments, etc. which are required during surgery or other aseptic procedures, are used on a daily basis in the normal operation of hospitals, clinics and the like. Where such products are not pre-packaged in a sterile state, it is necessary for the hospital or clinic to sterilize them before use. Furthermore, where these products are not disposable, and are employed more than once, it is necessary that they be cleaned and otherwise prepared for subsequent use. Prior to such use, however, it is essential that such products be sterilized.
Due to the volume of materials involved, it is often necessary to sterilize and store these products for later use. Accordingly, there has been developed a procedure where such products, after cleaning, laundering and the like, are wrapped in sterilization fabric and then sterilized and stored for subsequent use. Disposable sterilization fabric is typically cut into predetermined rectangular shapes and sold as sterilization wraps.
Traditional wrapping of a sterilization tray or similar articles in a conventional disposable sterilization wrap often involves a large amount of redundant material as excess corners and overlapping plies are gathered, folded, and secured together at the top of the sterilization tray.
Conventional disposable sterilization wrap is a flat, featureless sheet of material that may occasionally contain one or more additional layers of material for strength or absorbency. This flat, featureless configuration provides no information or guidance to a person wrapping an article with the flat sheet of material on how to wrap an article.
Conventional disposable sterilization wrap is frequently made of inexpensive, relatively impermeable material such as, for example, paper and the like. The properties of these materials have generally influenced folding techniques and wrapping configurations to ensure the sterility of the wrapped tray or article.
For example, U.S. Pat. No. 5,635,134 to Bourne, et al. discloses a multi-ply sterilization wrap which is formed by joining one or more sheets of sterilization wrap (e.g., two separate sheets or one sheet folded over) together to form two similarly sized, superposed panels that allow convenient dual wrapping of an article. As another example, U.S. Patent Application Publication No. 2001/0036519 by Robert T. Bayer discloses a two ply sterilization wrap that is formed of a single sheet of sterilization wrap material which is folded to form two similarly sized, superposed panels that are bonded to each other. As yet another example, U.S. Patent Application Publication No. 2005/0163654 by Stecklein, et al. discloses a sterilization wrap material that has a first main panel and a second panel that is smaller than the main panel. The second panel is superposed and bonded to the central portion of the main panel such that it is contained entirely within the main panel to reinforce the main panel and/or provide additional absorbency.
Generally speaking, in these and other examples, large sheets of conventional disposable sterilization wrap are typically used to create large expanses of overlapping materials using one or two standard fold techniques. Large amounts of materials and multiple folds are used to create a tortuous path (e.g., at least two sharp turns in the same direction) to inhibit passage of airborne bacteria past the edges of the sterilization wrap past the folds in response to changes in air pressure in the volume enclosed by the sterilization wrap. That is, large amounts of material and multiple folds are a conventional technique used to address a “bellows effect” from handling or dropping of wrapped contents that may cause rapid volume and pressure changes that force air out of and back into the wrapped package past the edges and folds of sterilization wrap enclosing the content that has been sterilized. The principle of employing a tortuous path to maintain sterile conditions is sometimes referred to as Louis Pasteur's tortuous path principle or theory.
These conventional techniques and the resulting fold configurations require manipulating excess amount of materials during the wrapping and unwrapping process. It takes experience and a certain level of skill to wrap a tray or similar article quickly and reliably. Because of scheduling and cost pressures, medical equipment needed for some procedures may require immediate turnaround and must be processed, sterilized and available for use within hours of its use in a previous procedure. As turnaround times continue to compress, there is a corresponding increase in the need to wrap an article even more quickly while ensuring the integrity of the wrapping.
Errors during the wrapping of an article prior to sterilization or during the unwrapping of a sterilized article in the operating room have important financial and time consequences. Improperly wrapped packages are more likely to become compromised by aggressive handling or excessive amounts of routine handling. A contaminated article requiring re-sterilization can delay a critical medical procedure. A typical hospital may spend approximately fifty-thousand dollars ($50,000.00 US) annually on sterilization wrap, sterilization pouches or sterilization containers. Failure of the sterilization wrap, pouch or container, and/or errors related to wrapping or unwrapping will require re-sterilization of the contents if another sterilized substitute is not immediately available. If there is any doubt about the sterility of any item, it must be re-sterilized. Depending on the procedure, it may cost up to eight-thousand dollars ($8,000.00) to reschedule a single medical procedure. Thus, the cost of only a few negative events may add up to a significant portion of what is spent on sterilization wraps, pouches, or containers.
There are many ways items conventionally wrapped or packaged in sterilization wraps can be contaminated. For example, soil, moisture, and bacteria can be forced into the package by incorrect or excessive handling, poor storage facilities, or improper techniques. As noted above, an aerosol or bellows effect always occurs, to some extent, by the squeezing action of the hands each time the package is handled. Dropping a package onto a hard surface such as a floor can also create a bellows effect by rapidly compressing the volume of the package which then recovers some or all of its volume and/or which may allow bacteria to enter the package through ruptured seals or small breaks or tears of the material that are not easily detected. Incorrect opening of the package may compromise the sterility of the contents of the package.
Certain modes of wrap failure such as knife cuts, abrasion and punctures are well-recognized. There are other modes of failure that are as common if not more common. These include pressure cuts, snag cuts and pressure holes.
A pressure cut can appear as a knife cut, but upon closer examination, the fibers around the very edge of the cut have been “welded” or stuck together. The edge of the cut may feel hard to the touch. This type of cut usually follows the perimeter or outline of the bottom of the instrument tray. It may also occur on the top of the instrument tray, if a number of trays have been stacked upon one another. An example of a typical event that may generate a pressure cut would be lifting the front end of a 20 pound tray so that all the weight of the tray is resting on a back edge, and pulling it across the storage shelf before lifting. This is similar to cutting the wrap with scissors; the material is caught between two layers of hard solid interfaces with a shearing action applied to the material.
In a snag cut, the edges of the cut show loose fibers hanging and/or there are individual fibers spanning across the width of the cut. The edges of the cut are not rough or hard, as with the pressure cut. In larger snag cuts, the shape of the cut area resembles a triangle, with the point of the triangle being where the snag began. The snag cut will occur along the edges of the wrapped instrument tray if the tray is very loosely wrapped. Otherwise, this type of cut will occur on the other areas of the tray where the wrap is too loose and can be caught by rough surfaces or corners. This type of cut is generally due to the tray being pulled or dragged across a roughened surface, often an older, well-used sterilizer cart. This cut can also occur when a loosely wrapped area of a tray gets caught on the corners or edges of objects.
A pressure hole may appear to be a tiny opening where the fibers around the very edge of the hole have been “welded” or stuck together. This type of hole is usually found along the perimeter of the bottom of an instrument tray. It may also occur on the top of the instrument tray if a number of trays have been stacked upon it. An example of a typical event that may generate a pressure hole would be a tray being dropped (even a small distance) onto an edge of a cart or storage shelf while being transported to different areas of the hospital.
The use of large sheets of conventional disposable sterilization wrap with standard fold techniques provides large expanses of overlapping materials and multiple folds that are also generally thought to help protect against pressure cuts, snag cuts and pressure holes as well as the more commonly recognized modes of failure (i.e., knife cuts, abrasion and punctures). Accordingly, conventional solutions employ larger sheets of material, greater numbers of layers of material, combinations of large sheets of different materials, centrally located reinforcing or absorbent zones, bumpers or pads that are attached to the corners of trays, and combinations thereof—all of which require using and manipulating excessive amounts of material during the wrapping and unwrapping process, adding difficulty that slows the wrapping and unwrapping process, and creating waste.
Accordingly, there is an unmet need for an easy to use assembly, package or system that simplifies the task of wrapping or preparing an article for sterilization. There is also an unmet need for an easy to use package or system that simplifies the task of unwrapping a sterilized article. In addition to these needs, there is also a need for an arrangement, assembly or system of sterilization fabric that reduces or eliminates failures or breaches that compromises the sterility of the contents enclosed by the same. That is, a need exists for an assembly or system of sterilization wrap or fabric that reduces the occurrence of pressure cuts, pressure holes, snag cuts and the like while still reducing the amount of sterilization fabric needed for sterile processing of an instrument tray as well as reducing the complexity, difficulty and/or time required to wrap or cover the instrument tray. There is also an unmet need to reduce the amount of sterilization fabric needed for the sterile processing of an instrument tray.